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Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC)

Primary Purpose

Emphysema

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bronchoscopy
Lung Volume Reduction Coil (HEAT-LVRC)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe emphysema (recent CT-scan (< 6 mois) )
  • Age > 35 ans
  • Modified Medical Research Council Scale (mMRC) > 2
  • Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45%
  • Residual volume > 175%
  • Total Pulmonary capacity > 100%

Exclusion Criteria:

  • Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator
  • Carbon Monoxide Diffusing Capacity (TLCO) < 20%
  • Recurrent respiratory infection Infections with clinics symptoms
  • Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg
  • Impossibility to walk more that 140 meter (6 min test)
  • Surgery history of volume reduction or pulmonary transplantation
  • Broncho-dilatation with clinic symptoms

Sites / Locations

  • Larrey Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient with severe emphysema

Arm Description

Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy

Outcomes

Primary Outcome Measures

Hyperinflation Assessment After Treatment
Assessed by Lung Volume Reduction Coil

Secondary Outcome Measures

Full Information

First Posted
July 13, 2016
Last Updated
August 19, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02835001
Brief Title
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil
Acronym
HEAT-LVRC
Official Title
Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
change of technique
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema
Detailed Description
Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with severe emphysema
Arm Type
Other
Arm Description
Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
Two sequences of 30 minutes are necessary by patient
Intervention Type
Device
Intervention Name(s)
Lung Volume Reduction Coil (HEAT-LVRC)
Intervention Description
Bronchoscopy with Heat-LVRC
Primary Outcome Measure Information:
Title
Hyperinflation Assessment After Treatment
Description
Assessed by Lung Volume Reduction Coil
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe emphysema (recent CT-scan (< 6 mois) ) Age > 35 ans Modified Medical Research Council Scale (mMRC) > 2 Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45% Residual volume > 175% Total Pulmonary capacity > 100% Exclusion Criteria: Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator Carbon Monoxide Diffusing Capacity (TLCO) < 20% Recurrent respiratory infection Infections with clinics symptoms Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg Impossibility to walk more that 140 meter (6 min test) Surgery history of volume reduction or pulmonary transplantation Broncho-dilatation with clinic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Guibert, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Larrey Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

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